Efficacy of Two Intermittent Subglottic Secretion
Primary Purpose
Ventilator Associated Pneumonia
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Subglottic secretion lavage combined with aspiration
Subglottic secretion aspiration
Sponsored by
About this trial
This is an interventional prevention trial for Ventilator Associated Pneumonia focused on measuring ventilator-associated pneumonia, subglottic secretion drainage, endotracheal tube, length of mechanical ventilation
Eligibility Criteria
Inclusion Criteria:
- patients aged between 18 and 80 years requiring mechanical ventilation for more than 72 hours with placement of an ETT( equipped with a dorsal suction catheter for subglottic secretion drainage)
Exclusion Criteria:
- Exclusion criteria were patients endotracheal intubation was performed before admission, history of HIV, immunosuppression, leukopenia, patient refusal,and
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Lavage combined with aspiration
Pure aspiration
Arm Description
Intermittent subglottic secretions lavage combined with aspiration
Intermittent subglottic secretions aspiration
Outcomes
Primary Outcome Measures
Incidence of ventilator-associated pneumonia
is pneumonia that occurs when an artificial airway is established and mechanically ventilated
Secondary Outcome Measures
Incidence of draining duct blockage
If mucus flow stopped during subglottic suctioning with a sudden increase of the negative pressure in the proximal port of the suction suggesting a probable occlusion
Full Information
NCT ID
NCT03871985
First Posted
February 19, 2019
Last Updated
March 11, 2019
Sponsor
The First Hospital of Jilin University
1. Study Identification
Unique Protocol Identification Number
NCT03871985
Brief Title
Efficacy of Two Intermittent Subglottic Secretion
Official Title
Efficacy of Intermittent Subglottic Secretion Lavage Combined With Aspiration Preventing Ventilator Associated Pneumonia in Patients With Severe Neurological Disease:A Single-center Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 15, 2019 (Anticipated)
Primary Completion Date
December 30, 2019 (Anticipated)
Study Completion Date
January 15, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Hospital of Jilin University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the efficacy of intermittent subglottic secretion lavage combined with aspiration preventing ventilator associated pneumonia in patients with severe neurological disease
Detailed Description
Ventilator-associated pneumonia (VAP) is a common and serious complication of mechanical ventilation. Many studies have shown that the accumulation of subglottic secretions above the endotracheal cuff plays an important role in the pathogenesis of VAP. Subglottic secretion drainage (SSD) has been shown to be associated with a lower incidence of VAP in previous meta-analyses. Most studies in past reported that in the group of patients in whom endotracheal tube (ETT) was used and subglottic secretion drainage was applied compared to the group without subglottic secretion drainage.Very few studies compared two different methods of SSD,such as subglottic secretion lavage combined with aspiration or pure aspiration.The tubes need frequent cleaning as they often get blocked, especially the draining duct. This may be the reason why they are not commonly applied. However,subglottic secretion lavage combined with aspiration can reduce the incidence of tube blockage.So The purpose of this study is to determine the efficacy of intermittent subglottic secretion lavage combined with aspiration preventing ventilator associated pneumonia in patients with severe neurological disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator Associated Pneumonia
Keywords
ventilator-associated pneumonia, subglottic secretion drainage, endotracheal tube, length of mechanical ventilation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
234 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lavage combined with aspiration
Arm Type
Experimental
Arm Description
Intermittent subglottic secretions lavage combined with aspiration
Arm Title
Pure aspiration
Arm Type
Active Comparator
Arm Description
Intermittent subglottic secretions aspiration
Intervention Type
Procedure
Intervention Name(s)
Subglottic secretion lavage combined with aspiration
Intervention Description
Ventilator-associated pneumonia preventive measures were applied to all patients according to VAP bundle. Subglottic secretion lavage combined with aspiration was performed every 4 hours: Underwent preoxygenation before cuff pressure checking, and was maintained between 30 and 35 cmH2O. After aspirating secretions from the mouth, nose, and airway, 2-5 mL distilled sterile water was instilled through the subglottic lumen, and then the negative pressure suction device is connected with the outer opening of the side cavity of endotracheal intubation for suction with a negative pressure of 100 mmHg, and each suction was kept under 15 seconds. Repeat lavage and aspiration until the irrigation fluid is clear. After washing, cuff pressure checking and was maintained between 25 and 30 cmH2O.
Intervention Type
Procedure
Intervention Name(s)
Subglottic secretion aspiration
Intervention Description
Ventilator-associated pneumonia preventive measures were applied to all patients according to VAP bundle. Subglottic secretion aspiration was performed every 4 hours:Underwent preoxygenation before cuff pressure checking ,and was maintained between 25 and 30 cmH2O. After aspirating secretions from the mouth, nose, and airway, the negative pressure suction device is connected with the outer opening of the side cavity of endotracheal intubation for suction with a negative pressure of 100 mmHg, and each suction was kept under 15 seconds. Repeat suction until the secretion is completely absorbed.
Primary Outcome Measure Information:
Title
Incidence of ventilator-associated pneumonia
Description
is pneumonia that occurs when an artificial airway is established and mechanically ventilated
Time Frame
through study completion, an average of 10 months
Secondary Outcome Measure Information:
Title
Incidence of draining duct blockage
Description
If mucus flow stopped during subglottic suctioning with a sudden increase of the negative pressure in the proximal port of the suction suggesting a probable occlusion
Time Frame
through study completion, an average of 10 months
Other Pre-specified Outcome Measures:
Title
length of mechanical ventilation
Description
length of mechanical ventilation
Time Frame
through study completion, an average of 10 months
Title
The coincidence rate between pathogens of subglottic secretions and the lower respiratory tract
Description
The coincidence rate between pathogens of subglottic secretions and the lower respiratory tract
Time Frame
through study completion, an average of 10 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients aged between 18 and 80 years requiring mechanical ventilation for more than 72 hours with placement of an ETT( equipped with a dorsal suction catheter for subglottic secretion drainage)
Exclusion Criteria:
Exclusion criteria were patients endotracheal intubation was performed before admission, history of HIV, immunosuppression, leukopenia, patient refusal,and
12. IPD Sharing Statement
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Efficacy of Two Intermittent Subglottic Secretion
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